Japan's Ministry of Health, Labour and Welfare (MHLW) has recommended approval for Regeneron ($REGN) and Sanofi’s ($SNY) alirocumab (Praluent), a spokesman for the ministry said, setting up competition in the PCSK9 inhibitor space with the Amgen ($AMGN) and Astellas therapy Repatha (evolocumab).
The recommendation, made last week by the Pharmaceutical Affairs and Food Sanitation Council’s First Committee on Drugs (PAFSC), said the therapy was endorsed to treat familial hypercholesterolemia in patients who have high risk of cardiovascular ailments and who do not respond to statins.
Just last month, Amgen won an initial round in a PCSK9 drug case in which a jury in the U.S. state of Delaware found that Sanofi has infringed on Amgen patents in the field. Regeneron and Sanofi plan to appeal the case.
In Japan, Repatha sales started in April with Amgen hailing initial momentum on the first quarter earning call.
Pricing was set at ¥22,948 ($205.37) for the treatment by Japan's National Health Insurance program--setting the stage for potential peak sales of ¥49.2 billion ($440 million) at the end of the decade with 69,000 patients seen on the therapy, according to data from the Central Social Insurance Medical Council (Chuikyo).
But MHLW has also cautioned doctors to curb unnecessary prescriptions.
The PAFSC also gave its backing for UCB Japan’s antiepileptic treatment, lacosamide (Vimpat) and an AbbVie ($ABV) fixed-dose combination of levodopa and carbidopa and Maruho’s propranolol to treat motor-skill loss in Parkinson’s disease patients.
As well, two orphan drug designations were backed, Genzyme Japan’s patisiran and Nippon Shinyaku’s selexipag.
- here's the MHLW website